Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)

Launched by NANDAN LAD, M.D., PH.D. · May 17, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring the use of Spinal Cord Stimulation (SCS) to help manage pain and improve rehabilitation for individuals with specific types of spinal cord injuries. The study will last about 12 months and involves two groups of participants. One group will receive SCS treatment combined with standard medical care, while the other group will receive standard care without the SCS. Participants will have two devices implanted: one to help with pain and another to assess improvements in movement and other functions.

To be eligible for this study, participants must be between 18 and 80 years old, have a traumatic spinal cord injury, and experience chronic pain for at least three months. They should also be able to attend appointments and complete necessary assessments. Throughout the trial, participants will receive regular medical care and rehabilitation. After three months, those in the group without SCS will have the opportunity to switch to the treatment group. The study aims to gather important information about how effective SCS is for improving pain and recovery in individuals with spinal cord injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement):
• • 1. Traumatic, thoracic SCI
• • 2. Chronic pain (i.e., Pain \>3 for \> 3 months)
• • 3. Willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires
• • 4. 18-80 years of age
• • 5. Medically stable enough to undergo surgical implantation of an SCS / participate in rehabilitation regimens
• Exclusion Criteria:
• Subjects enrolled in this study must not meet any of the following exclusion criteria (based on investigator judgement):
• • 1. Complete cord transection
• • 2. Persistent spinal instability or other injury preventing ability to participate
• • 3. Active infection
• • 4. Comorbid psychosis or psychotic disorder
• • 5. Untreated, clinically significant depression
• • 6. Active drug or alcohol abuse
• • 7. Pregnant women or women who intend to become pregnant during the duration of the study. Women of childbearing potential need a negative pregnancy test